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Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms

NCT04781530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 522

Last updated 2025-04-18

No results posted yet for this study

Summary

This study is a randomized controlled trial where participants are randomly assigned in a 1:1 ratio to either a rapid test group or a control group. Standard care is provided in the control group. Follow-up is conducted until discharge from the hospital, followed by telephone check-ins and completion of questionnaires by the participants themselves or their proxies until 30 days after randomization. Children of any age presenting at selected participating sites with acute respiratory tract infections, where initial treatment decisions are uncertain, are eligible to participate. The study aims to enrol 520 participants and involves Paediatric Emergency Rooms across Europe.

Conditions

  • Community-acquired Acute Lower Respiratory Infection

Interventions

DEVICE

BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)

BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus): Nasopharyngeal swab

Sponsors & Collaborators

  • BioMérieux

    collaborator INDUSTRY

  • Universiteit Antwerpen

    collaborator OTHER

  • St George's, University of London

    collaborator OTHER

  • University Children's Hospital Basel

    collaborator OTHER

  • PENTA Foundation

    lead NETWORK

Principal Investigators

  • Julia Bielicki, PhD · St George's, University of London

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2024-01-25
Completion
2024-01-25

Countries

  • Germany
  • Greece
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04781530 on ClinicalTrials.gov